An observational study in Excessive Daytime Sleepiness, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 2 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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Among 30 studies in Disorders of Excessive Somnolence with a site in France — 9 open to participants now, 10 under way, 4 of them phase 3. Disorders of Excessive Somnolence · France.
Among the 30 studies in Disorders of Excessive Somnolence with a site in France, this one is the only one that started in 2023, is one of 6 observational ones, and was the 18th registered.
196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
Browse Disorders of Excessive Somnolence studies →9 of the 30 studies in Disorders of Excessive Somnolence with a site in France are open now. Recruiting first, the newest first:
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
University Hospital, Bordeaux · Sites in France
Ages 18–65 · Healthy volunteers
Alkermes, Inc. · Sites in France, United States, Australia and 5 more countries
Ages 18–70
Hospices Civils de Lyon · Sites in France
Ages 18–65
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 13
First in 2003; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 102 is close to the median of 104 across 29 observational studies indexed under Disorders of Excessive Somnolence.
Median enrollment 130 across the 24 interventional studies, 110 across the 6 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 30 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 2 studies filed under Disorders of Excessive Somnolence — fewer than ten, so there is no comparison to draw.
7 of the studies in Disorders of Excessive Somnolence with a site in France that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06366464Phase 3Harmony Biosciences Management, Inc.A Study of Pitolisant in Patients With Prader-Willi Syndrome | 2027-04 |
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT06457945Hospices Civils de LyonMind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions | 2026-12-03 |
Add all 7 to your calendar (.ics) → With an account.
Among the 30 studies in Disorders of Excessive Somnolence with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.
In elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:
In order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.
The aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects.
Developed in 1991 by Dr. Johns at the University of Melbourne and modified by him in 1997, the Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.
In elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:
In order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.
The aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects
Seniors with suspected sleep disorders referred for assessment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Seniors with suspected sleep disorders referred for assessment
Other: Test of an alternative Epworth Sleepiness Scale ESS-ALT in French
Seniors recruited into the study will test the Epworth Alternate Sleepiness Scale -ALT
Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French
forward and backward translation" between English and French, and correlation with the ESS sleepiness scale.
Time frame: 24 hours
Study of the correlation between the results of the French ESS-ALT and polysomnography data
Statistical comparison to identify the intrinsic validity of the ESS-ALT
Time frame: 24 hours
Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data
Statistical comparison to identify the intrinsic validity of the ESS-ALT
Time frame: 24 hours
intrinsic validity of the ESS-ALT in French
Statistical comparison to identify the intrinsic validity of the ESS-ALT
Time frame: 24 months
Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany
Statistical comparison to identify the intrinsic validity of the French version of ESS-ALT
Time frame: 24 months
Ran from Jun 2023 to primary completion in Oct 2023, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Disorders of Excessive Somnolence →
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